Delving into the Latest Updates on TuBerculosis Vaccine Initiative with Synapse

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Immune System Diseases

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Live attenuated vaccine

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Disease Domain	Count

Immune System Diseases	1
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Live attenuated vaccine	1
Prophylactic vaccine	1

The objective of this project is to demonstrate safety, immunogenicity and improved efficacy of the new live attenuated M. tuberculosis vaccine called MTBVAC in a Phase 3 efficacy trial in HIV-uninfected infants born to HIV-infected and HIV-uninfected mothers as compared to standard of care BCG vaccination. The proposal builds upon a group of TB vaccine development partners in Europe and sub-Saharan Africa established in a previous EDCTP-supported project. It creates an expanded consortium of clinical trial partners for the optimal implementation of a large infant efficacy trial of MTBVAC in high TB incidence settings. New capacity for efficacy trials in infants will be a valuable resource for the TB vaccine development community. The proposal will create a network of institutions in three TB endemic African countries with enhanced laboratory capacity to conduct TB vaccine immunology studies and to bio-bank samples to discover immune correlates of vaccine-mediated protection.

Start Date17 Oct 2022

Sponsor / Collaborator

Biofabri SL

[+7]

NCT03536117

/ CompletedPhase 2

Phase 2a Dose-Defining Safety and Immunogenicity Study of MTBVAC in South African Neonates Living in a High-Burden Tuberculosis-Endemic Region

A Phase 2a dose-defining study of MTBVAC to evaluate the safety, reactogenicity, immunogenicity, and potential for IGRA conversion and reversion, of MTBVAC in South African newborns. Ninety-nine HIV unexposed, BCG naïve newborns will be randomized to receive either BCG 2.5 x 105 CFU (n=24) or MTBVAC at one of three dose levels (n=75). Allocation will be double blind. Enrolment will be sequential into 3 cohorts of increasing MTBVAC dose (Cohort 1: n=25 MTBVAC 2.5 x 10E+04 and n=8 BCG; Cohort 2: n=25 MTBVAC 2.5 x 10E+05 and n=8 BCG; Cohort 3: n=25 MTBVAC 2.5 x 10E+06 and n=8 BCG). Dose escalation will be staggered to allow gradual evaluation of safety; final selection of the dose for Cohort 3 will be based on all available safety and immunogenicity data.

Start Date12 Feb 2019

Sponsor / Collaborator

Biofabri SL

[+3]

NCT03767946

/ CompletedNot ApplicableIIT

MTBVAC in Newborns: Epidemiological Study In Tuberculosis-Endemic Regions of Sub-Saharan Africa

A cross-sectional childhood M. tuberculosis infection survey of age-specific rates (defined by positivity to the test QuantiFERON-TB Gold Plus) will be conducted in Senegal to collect information on the local TB endemic to inform site selection, sample size, and recruitment strategies for a future efficacy trial of vaccine candidate MTBVAC in young children.

Start Date27 Jul 2018

Sponsor / Collaborator

Biofabri SL

[+4]

100 Clinical Results associated with TuBerculosis Vaccine Initiative

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0 Patents (Medical) associated with TuBerculosis Vaccine Initiative

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News (Medical) associated with TuBerculosis Vaccine Initiative

20 Jun 2024

·www.tbvi.eu

Biofabri and TBVI sign a contract with the European Health and Digital Executive Agency to accelerate the final development of the new TB vaccine MTBVAC

Biofabri and TBVI have signed a contract with the European Health and Digital Executive Agency (HaDEA) under the EU4Health Programme to accelerate the final development of the MTBVAC vaccine. MTBVAC is a highly promising vaccine candidate that has the potential to be used as an alternative to BCG vaccination in infants and for prevention of TB disease in adolescents and adults. Through the EU4Health Programme, HaDEA’s support will accelerate the final stages of the clinical development of MTBVAC by supporting a Phase 3 clinical trial in neonates, which is currently well underway in various African countries. The trial aims to evaluate the protective efficacy, safety and immunogenicity of a single dose of MTBVAC administered by intradermal route in healthy HIV-unexposed and HIV-exposed neonates. A safe, effective and accessible new TB vaccine such as MTBVAC will be essential to stop the development and spread of both drug sensitive and drug-resistant TB. Please read the Press release: Biofabri and TBVI sign contract with HaDEA

Phase 3Vaccine

100 Deals associated with TuBerculosis Vaccine Initiative

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100 Translational Medicine associated with TuBerculosis Vaccine Initiative

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Pipeline

Pipeline Snapshot as of 08 Jun 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 3 Clinical

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